Amphastar Pharmaceuticals sues FDA over seizure of heparin
A Southern California pharmaceutical firm engaged in fierce competition to develop a generic version of a big-selling blood thinner sued the Food and Drug Administration on Monday, accusing the agency of illegally seizing an ingredient the company needed to pursue its application for the anticoagulant.
The suit, by Amphastar Pharmaceuticals Inc. of Rancho Cucamonga, alleges the FDA did not have the authority to quarantine two shipments of Chinese-manufactured heparin last summer, because they were being transferred between subsidiaries of the same company and were intended for research, not for treating humans.
The seizure of the heparin is part of “a broader pattern of arbitrary, capricious and vindictive behavior” that also included numerous unwarranted inspections of Amphastar facilities and a refusal to meet with the company to explain agency actions, according to the complaint, which seeks a court order to release the heparin and to end further FDA seizures of the substance.
An FDA spokeswoman declined to comment on the suit, which was filed in federal court in Washington.
Amphastar’s filing is the latest chapter in a tangled, long-running controversy involving efforts by three teams of drug makers to develop a generic version of Lovenox, a blockbuster drug used to prevent and treat blood clots.
The suit also spotlights the importance of pharmaceutical ingredients from China and the issues connected to tracking and regulating them.
With 2009 sales of $4.5 billion, Lovenox, made by France’s Sanofi-Aventis, was the 15th-best-selling drug in the world.
Amphastar, teaming with Watson Pharmaceuticals Inc. of Corona, applied in 2003 for approval to make the generic form of Lovenox, known as enoxaparin. Its main competitor, a pairing of Momenta Pharmaceuticals Inc. of Cambridge, Mass., and German drug maker Sandoz, filed its enoxaparin application in 2005 and won FDA approval this July.
Israel-based Teva Pharmaceutical Industries Ltd. also has an enoxaparin application.
Even as a generic, enoxaparin may be a blockbuster, garnering $292 million in sales in its first two months or so on the market, according to Sandoz’s corporate parent, Novartis.
The suit does not offer a motive for the FDA’s alleged overreaches. But Amphastar last year accused the agency’s top drug official, Janet Woodcock, of a conflict of interest in reviewing Amphastar’s application because of her ties to Momenta personnel.
The Department of Health and Human Services’ inspector general dismissed Amphastar’s complaint.
Woodcock worked with Momenta scientists in early 2008 to trace the chemical cause of contamination of Chinese heparin sold by Baxter International Inc. of Deerfield, Ill. The FDA linked the tainted heparin to the deaths of at least three people, and Baxter faces a wave of lawsuits alleging that the contamination was responsible for dozens of other illnesses and deaths.
The type of heparin involved in the Baxter case is the basic ingredient in enoxaparin.
The Woodcock-Momenta inquiry traced the chemical responsible for the contamination to an additive that stretched the supply of heparin, but did not pin down how the doctoring occurred or who did it.
In recent months, the FDA’s heparin investigation has come under scrutiny by congressional Republicans who worry that by failing to determine the ultimate source of the contamination, the agency has increased the chances for similar adulteration to occur in the future.
In its suit, Amphastar said the seized heparin came from a Chinese subsidiary and is needed for testing so that the subsidiary can be FDA-qualified as a source, thereby giving Amphastar control of its entire heparin supply chain.
